(89 days)
The FiberDent Corporation Orascope™ is a non-diagnostic fiberoptic visualization device used to illuminate and magnify dental surfaces.
The Orascope consists of a flexible fiberoptic probe with sterile disposable sheath. The probe feeds magnified images from within the oral cavity. The flexible fiberoptic probe transmits the image information and light to and from the oral cavity. A light source transmits light through the fiber to illuminate the target area. Real time image information from the target area is transmitted through the fiber to a CCD color camera which sends this information to the flat screen display monitor to be viewed by the user. The flat screen display is mounted on a wheeled flexible stand which can be positioned for optimum viewing comfort. The Orascope enhances the dentist's ability to see within the oral cavity.
The Orascope consists of the fiberoptic endoscope and sterile disposable sheath. A digital camera, monitor and video printer are also offered as accessories to the Orascope.
Orascope Fiberoptic Dental Endoscopes:
The Orascope consists of a flexible fiberoptic probe which contains both lightemitting fibers and image transmission fibers. The light emitting fibers gather light from a high-intensity light source affixed to the wheeled display stand. The light shines out the probe tip to illuminate the field-of-view for the image transmission fibers. The image transmission fibers transmit the image from the end of the probe tip back to the wheeled display stand where the color video camera creates the electronic image for display on the display screen. The Orascope is offered in both 0.9 mm and 1.8 mm tip outer diameter sizes. Each probe contains light conducting fibers for the illumination of the probe's field-of-view as well as image conducting fibers for optical transmission of the image of the field-of-view to the camera.
Sterile Disposable Sheath:
The sterile disposable sheath is a single use closed end sheath which covers the end of the probe for about 100 mm. This sheath has been subjected to USP Class VI biocompatibility test results and cytotoxicity testing. Viral Penetration testing has been performed on the sheaths. The test results showed that virus (bacteriophagy) did not penetrate the film or the heat seals of the sheaths tested.
Camera:
The camera offered with the Orascope is a Panasonic GP-US522 three-chip color CCD camera with remote head. The GP-US522 is a standard three-chip color CCD camera with a resolution of 768 (H) x 494 (V). The camera operates on 12 VDC. The camera is used to capture a video image from the Orascope fiber-optic probe(s) and provide an S-Video signal for display by the video monitor.
Video Monitor:
The video monitor offered with the Orascope is a National Display Systems 15" XGA Flat Panel Video Display Monitor Model #DSW-X15-N. This flat-screen video display monitor operates from the S-Video signal provided by the camera. The monitor operates on 12 VDC.
Light Source:
The light source is a Cuda Products Corporation dual channel Xenon-quality fiberoptic light source. The MX2-300 operates on 120 VAC and provides illumination from one of two metal-halide bulbs. Dual channel means that the light source contains two bulbs. If one bulb burns out during a procedure, the light source can be configured so that the second bulb can be used within seconds. The light from the bulb is reflected onto a fiberoptic light-guide which is plugged into the cable receptacle on the front of the MX2-300.
Here's a breakdown of the acceptance criteria and study information for the FIBERDENT CORPORATION ORASCOPE, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC/EMI | Radiated Electromagnetic Immunity (EN 61000-4-3 & ENV 0204) | Passed |
| Electromagnetic Interference (EN 55022) | Passed | |
| Conducted Electromagnetic Immunity (EN 61000-4-6:1996) | Passed | |
| Power Frequency Magnetic Field Immunity (EN 61000-4-8:1993) | Passed | |
| Electrostatic Discharge Immunity (EN 61000-4-2:1995) | Passed | |
| Limits for Harmonic Current Emissions (IEC 1000-3-2:1995) | Passed | |
| Voltage Dips, Interrupts and Variations (IEC 1000-4-11:1994) | Passed | |
| Surge Immunity (IEC 1000-3-2:1995) | Passed | |
| Electrical Fast Transient/Burst Immunity (EN 61000-4-4:1995) | Passed | |
| Biocompatibility | USP Class VI biocompatibility test results | Performed, results implied acceptable |
| Cytotoxicity testing | Performed, results implied acceptable | |
| Integrity (Sterile Sheath) | Viral Penetration testing (bacteriophagy) | "Virus did not penetrate the film or the heat seals of the sheaths tested." |
2. Sample Size Used for the Test Set and Data Provenance
Specific information regarding the sample size for a "test set" and data provenance (e.g., country of origin, retrospective/prospective) for clinical performance is not provided in this 510(k) summary. The summary focuses on electrical safety, EMC/EMI, and material integrity testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided as the device is described as a "non-diagnostic fiberoptic visualization device." There are no diagnostic claims requiring expert-established ground truth related to medical conditions. The testing described pertains to engineering and material safety standards.
4. Adjudication Method for the Test Set
This information is not applicable given the nature of the device and the testing performed (electrical, material, and electromagnetic standards). Adjudication methods are typically employed in studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The device's intended use is non-diagnostic visualization, and the provided testing is focused on safety and technical performance against established standards, not on diagnostic accuracy or reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (in the context of an algorithm's performance) was not done or reported. The Orascope is a physical optical device, not an AI algorithm.
7. The Type of Ground Truth Used
For the reported tests:
- Electrical Safety & EMC/EMI: Ground truth is established by the definitions and requirements of the cited industry standards (e.g., EN 61000 series, EN 55022, IEC 1000 series). "Passing" these tests means meeting the pre-defined limits and performance criteria outlined in those standards.
- Biocompatibility & Viral Penetration: Ground truth is established by the methodologies and acceptance criteria defined in USP Class VI and viral penetration testing protocols. For viral penetration, the "ground truth" for success was the absence of virus penetration.
8. The Sample Size for the Training Set
This information is not applicable or provided. The Orascope is a hardware device; there is no "training set" in the context of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided for the same reason as above.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.